July 27 - July 30

The FDA and the University of Texas Medical Branch, Galveston National Laboratory (UTMB) are sponsoring an annual training course 27-30 July 2020 on how to meet good laboratory practice (GLP) requirements in biosafety level (BSL)-4 facilities.

The event will be hosted at the National Ebola Training and Education Center in Omaha, Nebraska.

This course offers a unique opportunity for the regulatory and scientific communities to discuss complex issues in an interactive environment and identify and share best practices for ensuring nonclinical data quality and integrity in BSL-4 facilities.

Purpose of course

The purpose of this unique educational course is to provide a learning environment that:

Promotes collaboration

Provides tools for conducting clinical studies

Enhances mutual understanding of clinical, scientific, and regulatory complexities, and

Promotes the data quality and integrity derived from these regulated studies.

A heightened awareness of the complexities and uniqueness of high- and maximum-containment environments for high-consequence pathogens is the first step in initiating a dialog to find solutions for the planning and execution of studies where data generated will be used to support a regulatory decision. The result is a better-prepared cohesive community of clinical, scientific, and regulatory experts mutually engaged in, and committed to, the development, research, and approval of medical countermeasures for high-consequence pathogens.

Professionals who have experience with high-consequence pathogen clinical trials are encouraged to register, including:

Physicians

Scientists

Principal investigators

Physician assistants

Nurses and nurse practitioners

Pharmacists

Clinical laboratorians

Clinical research staff and clinical monitors

Regulators and regulatory reviewers

Policy-makers

IRB professionals

Industry sponsors

Course objectives and curriculum

Objectives

Formulate solutions to regulatory, operational, and cultural challenges for the conduct of clinical trials of medical countermeasures for high-consequence pathogens

Attendees will also learn from integrated scenarios, case studies based on real-life experiences, and expert panels, along with lectures from experts from FDA, the National Institutes of Health, the NETEC, and clinical biocontainment units (BCUs).